← Product Code [HPG](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG) · K823385

# ALES (K823385)

_Oms · HPG · Mar 9, 1983 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K823385

## Device Facts

- **Applicant:** Oms
- **Product Code:** [HPG](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG.md)
- **Decision Date:** Mar 9, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5900
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K823385](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K823385)

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